ILLUMISITE ILS-1000-CS (UDI 10884521837096)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521837096), received between Jun 17, 2024 and May 28, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K191394); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Application Network Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN EXTENDED BEYOND THE PLEURAL BOUNDARY, AND AS A RESULT, THE PATIENT EXPERIENCED A PNEUMOTHORAX. AFTER THE PNEUMOTHORAX, THERE WAS SYSTEM INACCURACY, AS THE LOCATION AND SHAPE OF THE LUNG CHANGED. A CHEST TUBE WAS USED TO RESOLVE THE ISSUE. IT WAS REPORTED THAT THE SUPERDIMENSION PORTION OF THE CASE WAS COMPLETED, THE PATIENT DID WELL, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Pneumothorax

  MAUDE report 25325143 ↗
• MalfunctionDec 17, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SYSTEM DISPLAYED AN OUT OF SENSING VOLUME MESSAGE WHILE PATIENT SENSOR TRIPLET (PST'S) WERE VISIBLE. ALL CABLES WERE REPLACED AND THE SYSTEM WAS RESTARTED MULTIPLE TIMES WITH NO RESOLUTION. A DIFFERENT LOCATABLE GUIDE FROM A DIFFERENT HOSPITAL WAS ATTEMPTED, AND AFTER A RESTART, THE SYSTEM CORRECTLY RECOGNIZED THE LOCATABLE GUIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828219 ↗
• InjuryNov 24, 2025Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS GLITCHING IN THE SOFTWARE WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PHYSICIAN WAS UNABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. UPON SERVICING, AN ACCURACY TEST WAS RAN AND PASSED. AFTER LETTING SYSTEM WARMUP, POINT CEM ON THE PHANTOM, THE CEM GREEN TARGET WAS MOVING AROUND A LOT AND LOOKED LIKE IT WAS FLICKERING. IN PROCEDURE APPLICATION, WHEN TRYING TO REGISTER AND TRYING TO POSITION THE PATIENT SENSORS, ALL THREE SENSORS AND LOCATABLE GUIDE (LG), EXTENDED WORKING CHANNEL (EWC) WERE HOVERING AROUND VIOLENTLY. AFTER TROUBLE SHOOTING THE PROBLEM, THE CONTINUOUS GUIDANCE SYSTEM (CGS) AND LOCATION BOARD WERE REPLACED. IN TESTING AGAIN, THE SYSTEM WAS LET TO WARM UP BEFORE COMPLETING ACCURACY TEST. ACCURACY TEST WAS COMPLETED AND PASSED. VERIFIED THAT PATIENT SENSORS AND LG/SEWC WERE NO LONGER HOVERING AROUND. SYSTEM WAS RETURNED TO PATIENT USE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23632446 ↗
• InjuryJul 21, 2025Data Problem; Data Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHITE ARTIFACTS WERE OBSERVED ON SCANS DURING USE OF A COMPUTED TOMOGRAPHY (CT) SCANNER. HOWEVER, WHEN LOOKING AT THE SCAN ON THE CT SCANNER THEY ARE NOT THERE. REQUESTED DICOM DATA SO THAT IT CAN BE REVIEWED FOR WHAT IS CAUSING THESE ARTIFACTS FROM APPEARING. THE CASE WAS CANCELLED, IT DID NOT HAPPEN DUE TO REASONS BESIDE THE ISSUES WITH THE CT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561745 ↗
• MalfunctionMar 13, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SYSTEM, THE MACHINE SHUT DOWN AFTER THE PHYSICIAN HAD COMPLETED THE SWEEP AND WAS ON LOCATION. THE SYSTEM WAS LEFT PLUGGED IN, BUT THE GREEN SWITCH WAS NOT LEFT ON, WHICH CONTRIBUTED TO THE SHUTDOWN. THE PHYSICIAN DID COMPLETE THE CASE, BUT WAS UNABLE TO USE THE DEVICE. THE PHYSICIAN DECIDED TO MOVE FORWARD WITH TAKING BIOPSIES UNDER FLUOROSCOPIC VISUALIZATION EVEN THOUGH THE NAVIGATION SYSTEM WAS NOT OPERABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 21594289 ↗
• MalfunctionFeb 6, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT PRE-OPERATIVELY, WHEN A SERVICE ENGINEER WAS ONSITE FOR A ROOM QUALIFICATION, A LOCATABLE GUIDE WAS FOUND TO BE OUT OF THE SENSING VOLUME NEAR THE EDGES OF THE LOCATION BOARD. A REPLACEMENT LOCATION BOARD WAS SHIPPED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT. UPON SERVICING, THE SENSING VOLUME WAS OFF BY 10 MILLIMETER. TEST BED WAS CREATED AND RAN ACCURACY CHECK TO COMPARE RESULTS. PROCEEDED WITH RE-MAPPING OF BED 1. ACCURACY RESULTS WERE BACK WITHIN TOLERANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327230 ↗
• MalfunctionJan 24, 2025Poor Quality Image; Unintended Application Program Shut Down; Poor Quality Image; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, DURING A ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE INTRAPERSONAL COMPUTER (IPC) HAD SHUTDOWN DURING SAMPLING AND A BLUE SCREEN POPPED UP SAYING THE IPC WOULD RESTART. THE IPC SHUT DOWN IMMEDIATELY AND RESTARTED. THE PATIENT WAS UNDER ANESTHESIA AND THE SURGEON WAS ABLE TO COMPLETE THE CASE USING FLUORO. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228901 ↗
• InjuryOct 8, 2024Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  ACCORDING TO THE REPORTER, DURING A ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE PROCEDURE APPLICATION HAD AN ERROR UPON LOADING WHICH WAS NOT RESOLVED VIA PHONE. DEVICE SERVICING WOULD BE NEEDED. THE PATIENT WAS ALREADY AT THE TABLE AND UNDER ANESTHESIA, AND HAD TO BE WOKEN UP DUE TO THE ISSUE. THE SUPERDIMENSION PORTION OF THE CASE WAS NOT COMPLETED NOR WAS THE CASE COMPLETED BY OTHER MEANS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20401428 ↗
• InjuryJun 17, 2024Display or Visual Feedback Problem; Application Network Problem; Application Program Problem; Display or Visual Feedback Problem; Application Network Problem; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS A SYSTEM INACCURACY. THE SYSTEM SHOWED THE PHYSICIAN WAS IN THE LEFT LOWER LOBE WHEN IT WAS ACTUALLY AT THE MAIN CARINA DURING THE FINAL STEP OF REGISTRATION VERIFICATION. THE PHYSICIAN TRIED AN ADDITIONAL 45 DEGREE CATHETER TO VERIFY IT WAS NOT A FAULTY CATHETER. THE PHYSICIAN ALSO COULD NOT GET THE BRONCHOSCOPE VIDEO TO FEED INTO THE TOWER. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE SUPER-DIMENSION PORTION OF THE CASE AND WAS NOT COMPLETED BY OTHER MEANS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19547708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191394. One submission often covers many models, so check the product and lot details in each record.

• Z-2008-2023 · May 22, 2023 · Open, Classified
  Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS